Abbisko Therapeutics Privacy Policy

This notice applies to individuals based in the EU where personal data about those individuals is processed by Abbisko Therapeutics Co., Ltd. (“Abbisko”) and who are participants in the following clinical trial:

ABSK021-301, A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study of ABSK021 to Assess the Efficacy and Safety in Patients with Tenosynovial Giant Cell Tumor, is sponsored by Abbisko, who is acted as Controller as defined by the EU General Data Protection Regulation (GDPR). If you are a research participant, in most instances, your personal data will be de-identified when transferred outside of the European Economic Area (EEA) and United Kingdom (UK) and replaced by a subject ID/code. This means your data such as your name and contact details will not be transferred.

If you are a trial clinician or a member of trial personnel (such a Clinical Research Associate) , we may process your personal data in order to ensure that individuals with the appropriate qualifications are working on the trial and that the trial is properly staffed in our role as sponsor.

Our lawful basis for each purpose is as below.

PurposeTypes of dataLawful basisRetention

Screening and recruitment

Demographic (name, country, contact details etc.) gender, ethnicity and Health Data

(Note: name/contact details replaced with unique identifier for sharing with Abbisko)

Article 6(1)(f) – legitimate interest and Article 9(2)(j) research purposes

25 years as per the EU Clinical Trials Regulation (536/2014)

15 years as per the UK Clinical Trials Directive (2001/20/EC)

Operations of the clinical trial

Gender, ethnicity, Health data

Article 6(1)(f) – legitimate interest and Article 9(2)(j) research purposes

25 years as per the EU Clinical Trials Regulation (536/2014)

15 years as per the UK Clinical Trials Directive (2001/20/EC)

Pharmacovigilance

Gender, ethnicity, Health and Trial data

Article 6(1)(c) legal obligation and Article 9(2)(i) necessary for ensuring high standards and quality of medicinal products

25 years as per the EU Clinical Trials Regulation (536/2014)

15 years as per the UK Clinical Trials Directive (2001/20/EC)

Trial personnel

Demographic (name, contact details)

Qualifications

Article 6(1)(b)- performance of a contract

25 years as per the EU Clinical Trials Regulation (536/2014)

15 years as per the UK Clinical Trials Directive (2001/20/EC)


Where we rely on our legitimate interest, our legitimate interest is the development of products which can support and treat those living with certain conditions. We are carrying out this clinical trial to explore whether this medical strategy and treatment and is safe and effective for humans.

We also rely on our legal obligation under the EU Clinical Trial Regulation (536/2014) and the UK Clinical Trials Directive (2001/20/EC) to ensure the safety of our participants.

All individuals have consented to be part of the clinical trial and can withdraw from the study at any time.

Rights

The GDPR provides certain rights for Data Subjects which include:

Right of access

You have the right to access personal data Abbisko hold about you,

Right to rectification

You have the right to have inaccurate data about you corrected.

Right to object

You have the right to object to processing in certain circumstances.

In the majority of cases, it will be free to exercise these rights and Abbisko will respond within a period of one month.

Please contact abbiskotx@kdpc.es  or dpo.abbiskotx@kdpc.uk  if you wish to exercise any of your rights.

Transfers

Abbisko is is based in the people’s republic of China (“China”), and as such your personal data will be transferred to China and to other trusted suppliers based in the United States all of which work under strict contract with Abbisko. We must inform you that currently China and the United States have a different data protection regime to the regime in the EU, which is not currently deemed to provide a comparable level of protection for the purposes of EU data protection legislation. To maintain security of this data, personal data is only transferred to Abbisko and its trusted suppliers when strictly necessary and under the EU’s Standard Contractual Clauses which provide safeguards for these transfers. We have put in place other safeguards to protect your personal data such as encryption and only your subject ID, gender, ethnicity, and research data will be sent outside of the EEA.

Abbisko has appointed a European Economic Area (EEA) Representative who you can contact directly if you have any questions or concerns about how we use your personal data during and after the clinical trial:

David Stone

abbiskotx@kdpc.es 

Kaleidoscope Data Privacy Consultants SL, Calle Balmes 173, 4-2, Barcelona 08006, España

Recipients

Categories of recipients who will have access to your personal data will be the trial site study team, and Abbisko’s study team, drug safety team, trial monitoring team and drug management board and also clinical trial and medicinal product regulators.

Retention

Personal Data will be retained for 25 years in line with the EU regulatory requirement for clinical trial data (EU Clinical Trials Regulation (536/2014)) and for 15 years as per the UK Clinical Trials Directive (2001/20/EC).

Contact

If you have any queries regarding the processing activities, you can contact our European Economic Area (EEA) representative: abbiskotx@kdpc.es.

Our Data Protection Officer can be contacted at dpo.abbiskotx@kdpc.uk. If we are unable to resolve your query, you may contact your local supervisory authority.

The Spanish supervisory authority can be contacted here:

Agencia Española de Protección de Datos | AEPD

The United Kingdom supervisory authority (the Information Commissioner’s Office) can be contacted here:

Information Commissioner's Office (ICO)

Last updated: 16 April 2024


Tel:(+86) 021-68912098

E-Mail:Bd@abbisko.com
    PR@abbisko.com
    IR@abbisko.com

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